CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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Model Number 180343 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Inflammation (1932)
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Event Date 01/18/2021 |
Event Type
Injury
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Manufacturer Narrative
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Clinical statement: the hospitalization was unrelated to use of the liberty select cycler, pd therapy, or other fresenius product(s).There is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
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Event Description
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It was reported that a peritoneal dialysis (pd) patient needed to cancel treatment and disconnect during fill 2 due to a medical emergency.Technical support assisted the patient with canceling treatment.Upon follow-up, the patient reported being hospitalized for fluid around his lungs.Upon additional follow up, the patient¿s pd nurse stated the patient was initially hospitalized with a diagnosis of the flu.However, after additional assessment and testing, the patient was diagnosed with pericarditis.The hospitalization was unrelated to use of the liberty select cycler, pd therapy, or other fresenius product(s).There is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.
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Manufacturer Narrative
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Plant investigation: no parts were returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
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